Too soon to market

• Published in: BMJ Vol. 315; no. 7118; pp. 1248 - 1249
• Main Authors: Dent, Thomas H S, Hawke, Simon
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 15.11.1997; BMJ Publishing Group LTD; BMJ Publishing Group
• Edition: International edition
• Subjects: Alzheimer's disease; Communication; Decision Making; Drug Approval; Drug Information Services; Editorials; Funding; Humans; Licenses; Pharmaceutical industry; Practice Patterns, Physicians; Prescription drugs; United Kingdom; United Kingdom > UK; United Kingdom; UK
• ISSN: 0959-8138; 0959-8146; 1468-5833
• DOI: 10.1136/bmj.315.7118.1248

[...]donepezil, a recently licensed drug for Alzheimer's disease, is supported by only one randomised controlled trial published in full, with follow up of just 12 weeks. 1 This is long enough to show a treatment effect but hardly useful for routine clinical practice, where the issue is one of longer term efficacy and safety. Riluzole, licensed recently for use in amyotrophic lateral sclerosis (a form of motor neurone disease), clearly has some efficacy, but because this is at best modest and the drug has no effect on muscle function, 3 its role in treatment is uncertain. 4 The unpublished data seen by the licensing authorities have not been scrutinised by the scientific community and may not have been peer reviewed, which limit their suitability for use in prescribing and funding decisions.